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A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

insulin degludec

insulin glargine

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IDeg

IGlar

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)

Secondary Outcome Measures

Area under the NN1250 concentration-time curve during one dosing interval at steady state

Full Information

NCT ID

NCT00964418

First Posted

August 24, 2009

Last Updated

January 19, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00964418

Brief Title

A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

Official Title

A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDeg

Arm Type

Experimental

Arm Title

IGlar

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days

Intervention Type

Drug

Intervention Name(s)

insulin glargine

Intervention Description

0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days

Primary Outcome Measure Information:

Title

Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)

Time Frame

0-24 hours (derived on treatment day 6)

Secondary Outcome Measure Information:

Title

Area under the NN1250 concentration-time curve during one dosing interval at steady state

Time Frame

0-24 hours (derived on treatment day 6)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group) Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

24263619

Citation

Korsatko S, Deller S, Mader JK, Glettler K, Koehler G, Treiber G, Urschitz M, Wolf M, Hastrup H, Sondergaard F, Haahr H, Pieber TR. Ultra-long pharmacokinetic properties of insulin degludec are comparable in elderly subjects and younger adults with type 1 diabetes mellitus. Drugs Aging. 2014 Jan;31(1):47-53. doi: 10.1007/s40266-013-0138-0.

Results Reference

result

PubMed Identifier

25581159

Citation

Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

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